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  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
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  • Have MDSS, your Authorized Representative, apply for a Certificate of Marketability on your behalf! more


  • Cosmetic Products in Europe
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HIGHLIGHTS
Keep up to date!

News and Views March 2017

New Medical Device Regulation (MDR) in Europe
Read more...

In-House Workshops
The "NEW CE" mark
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to make sure you’re ready to survive and thrive





EVENTS
Meet us!

8. Medical Device Networking Meeting
Hanover, April 27, 2017




Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

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contact us





Authorized Representative Services

What is so important about having an Authorized Representative?

Authorized Reporesentatives, Medical Device Safety ServiceNon-European Medical Device manufacturers exporting to Europe must designate an Authorized Representative, that is established in the European Community, to fulfill one aspect of the requirements for CE marking.

The Authorized Representative performs certain duties under the European Medical Devices Directives and acts as a legal interface between the Medical Device manufacturer and the EU Authorities. This is why MDSS was founded.  We meet the criteria for CE marking and, more importantly, MDSS has sufficient experience in Regulatory Affairs to provide this demanding and highly `responsible´ service!

Our Mission

MDSS forges powerful alliances and provides timely, comprehensive solutions for our clients´ protection, benefit and corporate endurance. We strive to provide the best representation in the ever changing maze of European Regulations.  

Our Goals

MDSS, your products´ first class address, will be synonymous with quality products and compliance with the European Medical Device requirements. Because each client is unique and different, MDSS provides a customized solution for each one.

Our Clients

MDSS serves both the Medical Device and the In Vitro Diagnostic Medical  Device industries worldwide. Our clients are successful in their local marketplace and have expanded their expertise into the European arena with MDSS as their Authorized Representative and Regulatory Partner.


Medical Device Directives Division [MDD]

Please click here to learn more about our MDD Division


In-Vitro Directives Division [IVDD]

Please click here to learn more about our IVDD Division

Active Implantable Medical Device Directive Division  [AIMDD]

Please click here to learn more about our AIMDD Division